Calypte announces India approval for HIV test

Jul 12 2007

Calypte Biomedical Corporation has announced that it has received registration and marketing approval for its Aware HIV-1/2 OMT (oral fluid) rapid test in India from the Central Drugs Standard Control Organisation, commonly referred to as the Drug Control Authority of India ("DCAI").

Roger Gale, Calypte's Chairman and Chief Executive Officer, stated, "As has been highlighted in recent news reports, India is at the forefront in the fight against HIV/AIDS and we have seen strong interest in our oral fluid tests from both the Government and private sectors. A Calypte team has just returned from India where we have begun putting in place the infrastructure to access and build on this important business opportunity. We expect the market for HIV diagnostic testing in India to grow significantly in the next few years."

Mr. Gale continued, "This DCAI approval is a significant milestone in the advancement of our business; a very exciting time for all of us at the Company. Once our non-invasive HIV diagnostic tests gain market acceptance, we anticipate significant growth in market share of such tests. In addition to creating a distribution network, we expect to establish both research and manufacturing operations in India. While we will initially enter the Indian market with our HIV-1/2 oral fluid rapid test, we are also considering introducing our Aware(TM) HIV-1/2 rapid tests using both blood and urine samples to complement the current oral fluid test. India is also a logical center for development of Calypte's new products."

India has a population of over 1.1 billion, second only to China. According to recently published 2006 estimates by the National AIDS Control Organization or NACO, supported by both UNAIDS and WHO, India has an estimated 2.5 million HIV infections, ranking third behind South Africa and Nigeria for the highest number of HIV/AIDS infected people. Mr. Naresh Dayal, Secretary Health and Chair of the National AIDS Control Board said, " ... we cannot be complacent. The steady and slow spread of the HIV infection is a worrying factor."

The announcement of these new HIV estimates coincides with the launch of a 5-year, $2.8 billion AIDS campaign by the Government of India to prevent the spread of the virus among the country's large under-25 population. Calypte believes that a simple and cost effective non-invasive rapid test is an ideal solution to safely and quickly identify HIV/AIDS patients for treatment and care in large-scale programs such at this.